Interferometric detection and quantification system and methods of use in aquatics

ABSTRACT

A point of use analyte detection and quantification system for aquatic applications is provided. Related methods are also provided.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. Ser. No. 17/448,079filed Sep. 20, 2021, which claims priority to U.S. ProvisionalApplication No. 63/080,204, filed Sep. 18, 2020, the contents of whichare incorporated herein by reference.

BACKGROUND

Microorganisms are of great importance to aquaculture by recyclingnutrients, degrading organic matter and infecting and/or killing animalssuch as fish. Alternatively, some microorganisms may protect fish andlarvae against disease. In addition, monitoring for the presence ofchemical contaminants and components is equally important to aquacultureand water systems as a whole. Thus, detecting, monitoring, and takingremedial action against the microbial communities, chemical imbalance,or chemical contaminants in aquaculture environments may affect waterquality and control the development of microbial infection. There existsa need for rapid, efficient in vitro diagnostic systems that can provideusers with information pertaining to qualitative and quantitative datafor a variety of pathogens and/or chemicals.

SUMMARY

A portable interferometric system for detection and quantification ofanalyte within an aquatic test sample composition is provided. Thesystem includes an optical assembly unit, the optical assembly unitcomprising a light unit and a detector unit each adapted to fit within aportable housing unit; and a cartridge system adapted to be inserted inthe housing and removed after one or more uses, the cartridge systemcomprising an interferometric chip and a flow cell wafer. Theinterferometric chip includes one or more waveguide channels having asensing layer thereon, the sensing layer adapted to bind or otherwise beselectively disturbed by one or more analytes within the aquatic testsample composition.

According to one embodiment, the portable housing is sized and shaped tofit in a user's hand. According to one embodiment, the portableinterferometric system further includes at least one display unit.According to one embodiment, the portable interferometric system furtherincludes an external camera, the external camera adapted to capture aphoto or video. According to one embodiment, the portableinterferometric system includes an alignment means for aligning thecartridge system within a cartridge recess in the interferometricsystem. According to one embodiment, the sensing layer includes one ormore antigens, antibodies, DNA microarrays, polypeptides, nucleic acids,carbohydrates, lipids, or molecularly imprinted polymers, orimmunoglobulins suitable for binding one or more analytes within anaquatic test sample composition. According to one embodiment, theportable interferometric system is configured to analyze the lightsignals from two or more waveguide channels to detect the presence of ananalyte that individual waveguides could not have detected alone.According to one embodiment, the one or more waveguide channels eachcomprises a different sensitive layer to allow the system to detectdifferent analytes on each waveguide channel. According to oneembodiment, the sensitive layer is configured to bind one or morechemical, antibody, virus antigen, virus protein, bacteria, fungi,pathogen, RNA, mRNA, plant growth regulator, metal or any combinationthereof. According to one embodiment, the portable interferometricsystem exhibits an analyte detection limit down to about 1.0 picogram/L.According to one embodiment, the portable interferometric systemexhibits an analyte detection limit down to about 1000 pfu/ml. Accordingto one embodiment, the portable interferometric system exhibitssensitivity to at least 2 pixels per diffraction line pair. According toone embodiment, the portable interferometric system further includes alocation means adapted to determine the physical location of the system.According to one embodiment, the analyte is one or more of a fungicide,herbicide, insecticide, fungus, bacterium, or microbe.

A method of detecting and quantifying the level of analyte in an aquatictest sample composition is provided. The method includes the steps of:

-   -   collecting an aquatic target sample containing one or more        analytes;    -   optionally entering an identification associated with the target        sample;    -   introducing the aquatic target sample to an interferometric        system as provided herein;    -   optionally, mixing the target sample with a buffer solution to        form an aquatic test sample composition;    -   initiating waveguide interferometry on the test sample        composition;    -   processing any data resulting from the waveguide interferometry;        and    -   optionally, transmitting any data resulting from the waveguide        interferometry. According to one embodiment, the step of        transmitting data includes wirelessly transmitting analyte        detection and quantification data to a mobile device or server.        According to one embodiment, the method further includes the        step of displaying data related to the presence of analyte in        the test sample composition on the display unit. According to        one embodiment, the aquatic target sample composition is        collected from salt or freshwater within or surrounding an        aquatic environment.

According to one embodiment, the aquatic target sample is collected froma fish farm, effluent system, waterway, water reservoir, potable watersource or sanitary sewer. According to one embodiment, the method ofdetecting and quantifying the level of analyte in an aquatic test samplecomposition further includes the step of initiating a cleaning orremedial countermeasure against an analyte. According to one embodiment,the aquatic target sample is in the form of, dissolved in, or suspendedin a liquid or a gas. According to one embodiment, the data resultingfrom the waveguide interferometry is provided at or under 30 minutes.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a perspective view of one embodiment of a handheldinterferometric system as provided herein.

FIG. 2A illustrates a front view of one embodiment of a handheldinterferometric system as provided herein.

FIG. 2B illustrates a rear view of one embodiment of a handheldinterferometric system as provided herein.

FIG. 3A illustrates a cross-sectional view of an interferometric chipthat may be integrated into a cartridge system as provided herein.

FIG. 3B illustrates a bottom view of a flow cell wafer having aserpentine shaped detection microchannel.

FIG. 3C illustrates a top view of a chip illustrating the movement of anlight signal through the chip.

FIG. 4 illustrates a side view of one embodiment of an optical assemblytypically found in the handheld interferometric system of FIG. 1 .

FIG. 5A illustrates a cross-sectional view of the optical assembly ofFIG. 4 .

FIG. 5B illustrates an alignment means according to one embodiment.

FIG. 5C illustrates an embodiment of a top view of the optical assemblyand alignment means.

FIG. 6 illustrates the cross-sectional view of the optical assembly ofFIG. 5A with one embodiment of a cartridge system inserted in theoptical assembly.

FIG. 7 illustrates a top view of the optical assembly of FIG. 5A withone embodiment of a cartridge system inserted in the optical assembly.

FIG. 8A illustrates a view of the top surface of one embodiment of asingle-use cartridge system.

FIG. 8B illustrates a view of the bottom surface of one embodiment of asingle-use cartridge system.

FIG. 8C illustrates a view of the back surface of one embodiment of asingle-use cartridge system.

FIG. 8D illustrates a view of the front surface of one embodiment of asingle-use cartridge system.

FIG. 8E illustrates view of one side surface of one embodiment of asingle-use cartridge system.

FIG. 8F illustrates a cross-section view (looking downward) of asingle-use cartridge system along the horizontal line of FIG. 8E.

FIG. 9A illustrates a view of the top surface of one embodiment of amulti-use cartridge system.

FIG. 9B illustrates a view of the bottom surface of one embodiment of amulti-use cartridge system.

FIG. 9C illustrates a view of the back surface of one embodiment of amulti-use cartridge system.

FIG. 9D illustrates a view of the front surface of one embodiment of amulti-use cartridge system.

FIG. 9E illustrates a side surface view of one embodiment of a multi-usecartridge system.

FIG. 9F illustrates a cross-section view (looking downward) of oneembodiment of a multi-use cartridge system along the horizontal line ofFIG. 9E.

FIG. 10 illustrates a perspective view of an alternative single-usecartridge system.

FIG. 11 illustrates a method of detecting and quantifying the level ofanalyte in an aquatic test sample composition.

DETAILED DESCRIPTION

One or more aspects and embodiments may be incorporated in a differentembodiment although not specifically described. That is, all aspects andembodiments can be combined in any way or combination. When referring tothe compounds disclosed herein, the following terms have the followingmeanings unless indicated otherwise. The following definitions are meantto clarify, but not limit, the terms defined. If a particular term usedherein is not specifically defined, such term should not be consideredindefinite. Rather, terms are used within their accepted meanings.

Definitions

As used herein, the term “portable” refers to the capability of theinterferometric systems described herein to be transported or otherwisecarried to a target sample location for use according the methodsprovided herein.

As used herein, the term “chemical” refers to a form of matter, naturalor synthetic, having constant chemical composition.

As used herein, the term “aquatic” and “aquatic environment” refer toany a water-based environment that is a source for or may harboranalytes provided herein. The water-based environment may be fresh orsalt water based. Fresh water examples include, but are not limited to,ponds, lakes, reservoirs, rivers, streams, potable water sources,drainage canals and irrigation canals.

As used herein, the term “aquaculture” refers to the breeding, raising,and harvesting of a living organism in an aquatic environment. Theliving organism may be a plant, fish, mollusk, crustacean, plant oralgae according to one example. A specific example of aquaculture is afish farm, shrimp farm oyster farm, mariculture, or algaculture (e.g.,seaweed) farm.

As used herein, the term “analyte” refers to a substance that isdetected, identified, measured or any combination thereof by the systemsprovided herein. The analyte includes any solid, liquid, or gasaffecting (positively or negatively) an environment of interest. Theanalyte can be beneficial or deleterious. The analyte includes, but isnot limited to, chemicals as well as bacteria and other pathogenicmicroorganisms that may negatively or positively impact animal or planthealth or generally infect an aquatic environment. The analyte includes,but is not limited to microbes (beneficial or pathogenic that may bedead or alive), biomarkers, RNA, DNA, pathogen, antigen or portionthereof, antibody, virus, metabolite generated as a reaction to diseaseor infection, or viral protein. A chemical analyte may include anypesticide, herbicides (e.g., fluridone), insecticides, plant growthregulators, biocides, nutrients, polychlorinated biphenyls (PCB),volatile organic compounds (e.g., benzene, toluene, ethylbenzene andxylenes), tetrachloroethylene (PCE), trichloroethylene (TCE), and vinylchloride (VC), gasoline, oil, nitrites, or metals. Specific analyteswithin the aquatic environment include 2,4-D (2,4-dichlorophenoxyaceticacid) and dicamba (2-methoxy-3,6-dichlorobenzoic acid).

As used herein, the term “pathogen,” “pathological,” “pathologicalcontaminant” and “pathological organism” refer to any toxin (e.g., algaltoxin), chemical, bacterium, virus or other microorganism (fungi,protozoa, etc.) that can cause disease for a member of the plant oranimal kingdom in an aquatic environment.

As used herein, the terms “sample” and “target sample” all refer to anysubstance that may be subject to the methods and systems providedherein. Particularly, these terms refer to any matter (animate orinanimate) where an analyte may be present and capable of beingdetected, quantified, monitored or a combination thereof.

As used herein, the term “point of use” refers to the applicability ofthe systems provided herein to be utilized by a user at or within theaquatic environment.

“Optional” or “optionally” means that the subsequently described eventor circumstance may or may not occur, and that the description includesinstances where said event or circumstance occurs and instances where itdoes not.

As used herein, the term “buffer” refers to a carrier that is mixed withthe target sample that includes at least one analyte.

As used herein, the term “test sample composition” refers to thecombination of at least one buffer and target sample.

As used herein, the term “aquatic test sample composition” refers to thecombination of at least one buffer and target sample taken from anaquatic environment.

As used herein, the term “communication” refers to the movement of air,liquid, mist, fog, buffer, test sample composition, or other suitablesource capable of carrying an analyte throughout or within the cartridgesystem. The term “communication” may also refer to the movement ofelectronic signals between components both internal and external to thecartridge systems described herein.

As used herein, the term “single-use” refers to the cartridge systembeing utilized in an interferometric system for a single test or assaybefore disposal (i.e., not re-used or used for a second time).

As used herein, the term “multiple-use” refers to the cartridge systembeing utilized for more than one test sample composition (e.g., assay)before disposal.

As used herein, the term “multiplex” refers to the cartridge systembeing utilized to detect multiple analytes from one target samplecomposition.

Optical Interferometry Principles

The systems provided include a detector that operates viaultrasensitive, optical waveguide interferometry. The waveguiding andthe interferometry techniques are combined to detect, monitor and evenmeasure small changes that occur in an optical beam along a propagationpathway. These changes can result from changes in the length of thebeam's path, a change in the wavelength of the light, a change in therefractive index of the media the beam is traveling through, or anycombination of these, as shown in Equation 1.

φ=2πLn/λ   Equation 1

According to Equation 1, φ is the phase change, which is directlyproportional to the path length, L, and refractive index, n, andinversely proportional to the wavelength (A) change. According to thesystems and methods provided herein, the change in refractive index isused. Optical waveguides are utilized as efficient sensors for detectionof refractive index change by probing near the surface region of thesample with an evanescent field. Particularly, the systems providedherein can detect small changes in an interference pattern.

According to one embodiment, the waveguide and interferometer actindependently or in tandem to focus an interferometric diffractionpattern. According to one embodiment, the waveguide, interferometer, andsensor act independently or two parts in tandem, or collectively tofocus an interferometric pattern with or without mirrors or otherreflective or focal median. According to one embodiment, the waveguideand interferometer exhibit a coupling angle such that focus is at anoptimum angle to allow the system to be compact and suited to beportable and hand-held.

Interferometric System Overview

The interferometric systems as provided herein are mobile (hand-held)and portable for ease of use in various environments. Theinterferometric systems include a weight and overall dimensions suchthat user may hold the entire interferometric system comfortably in onehand. According to one embodiment, the entire interferometric system isunder three pounds. Thus, the present disclosure provides a lightweight,handheld and easy-to-use interferometric system that can rapidly,precisely, and accurately provide detection and quantification ofanalytes in a variety of environments.

The systems as provided herein provide a high throughput modular design.The systems as provided herein may provide both qualitative andquantitative results from one or more analytes within a test samplecomposition. Particularly, the systems as provided herein maysimultaneously provide detection and quantification of one or moreanalytes from a target sample. According to one embodiment, bothqualitative and quantitative results are provided in real-time or nearreal time.

The interferometric systems provided herein generally include a housingfor various detection, analysis and display components. Theinterferometric system housing includes a rugged, stable, shell or case.The interferometric system housing can withstand hazards of use andcleaning or disinfection procedures of the case surface. Theinterferometric system housing may be manufactured from a polymer viavarious techniques such as injection molding or 3D printing. Theinterferometric system housing may be manufactured to include acoloration that provides the interferometric system housing with aparticular color or color scheme.

According to one embodiment, the interferometric systems provided hereininclude components that are sealed, waterproof or water resistant to theoutside environment to minimize opportunities for contamination of atarget sample. The overall arrangement of components within theinterferometric systems minimize harboring of contamination in anyhard-to-reach areas allowing for ease of disinfection.

The interferometric systems provided herein include a cartridge system.The cartridge systems provided herein integrate with one or moreindependent or integrated optical waveguide interferometers. Thecartridge systems provide efficient sample composition communicationthrough a microfluidic system mounted on or within the cartridgehousing. The cartridge is suitable for one or more analytes to bedetected in a single sample in a concurrent, simultaneous, sequential orparallel manner. The cartridge systems provided herein may be utilizedto analyze in a multiplex manner. That is, one test sample compositionwill be tested to determine the presence of multiple analytes at thesame time by utilizing a plurality of waveguide channels that interactwith the test sample composition.

The cartridge systems provided herein are easily removable anddisposable allowing for overall quick and efficient use without the riskof cross-contamination from a previous target sample. The cartridge maybe safely disposed of after a single use. Disposal after a single usemay reduce or eliminate user exposure to biological hazards. Accordingto one embodiment, the cartridge system includes materials that arebiodegradable, or recycled materials, to reduce environmental impact.The cartridge system may be cleaned and re-used or otherwise recycledafter a single use.

The cartridge system as provided herein may be suited for multiple orone-time use. The single-use cartridge system may be manufactured in amanner such that a buffer solution is pre-loaded in the microfluidicsystem. By providing the buffer solution pre-loaded in the single-usecartridge system, gas bubbles are reduced or otherwise eliminated. Aftera single use, the entire cartridge system is safely discarded orrecycled for later use after cleaning. Put another way, afterintroduction and detection of a test sample composition, the entiresingle-use cartridge system is not used again and, instead, discarded.

The cartridge systems as provided herein may be suited for multipleuses. According to such an embodiment, the cartridge system may be usedone or more times prior to the cartridge system being safely discardedor recycled. The cartridge system may also be cleaned and re-used orotherwise recycled after multiple uses. According to one embodiment, thecartridge system facilitates cleaning and re-tooling to allow thecartridge system to be replenished and returned to operation.

According to one embodiment, the interferometric systems as providedherein have an analyte detection limit down to about 10 picogram/ml.According to one embodiment, the systems as provided herein have ananalyte detection limit down to about 1.0 picogram/ml. According to oneembodiment, the systems as provided herein have an analyte detectionlimit down to about 0.1 picogram/ml. According to one embodiment, thesystems as provided herein have an analyte detection limit down to about0.01 picogram/ml.

According to one embodiment, the interferometric systems as providedherein have an analyte detection limit down to about 3000 plaque formingunits per milliliter (pfu/ml). According to one embodiment, the systemsas provided herein have an analyte detection limit down to about 2000pfu/ml. According to one embodiment, the systems as provided herein havean analyte detection limit down to about 1000 pfu/ml. According to oneembodiment, the systems as provided herein have an analyte detectionlimit down to about 500 plaque forming units per milliliter (pfu/ml).According to one embodiment, the systems as provided herein have ananalyte detection limit down to about 100 plaque forming units permilliliter (pfu/ml). According to one embodiment, the systems asprovided herein have an analyte detection limit down to about 10 plaqueforming units per milliliter (pfu/ml). According to one embodiment, thesystems as provided herein have an analyte detection limit down to about1 plaque forming units per milliliter (pfu/ml). According to oneembodiment, the systems as provided herein have an analyte detectionlimit to about 1 plaque forming units per liter (pfu/I).

According to one embodiment, the interferometric systems provided hereinprovide both qualitative and quantitative results at or under 60 minutesafter sample introduction to the system. According to one embodiment,both qualitative and quantitative results are provided at or under 30minutes. According to one embodiment, both qualitative and quantitativeresults are provided at or under 10 minutes. According to oneembodiment, both qualitative and quantitative results are provided at orunder 5 minutes. According to one embodiment, both qualitative andquantitative results are provided at or under 2 minutes. According toone embodiment, both qualitative and quantitative results are providedat or under 1 minute.

The interferometric systems as provided herein may be powered viaalternating current or direct current. The direct current may beprovided by a battery such as, for example, one or more lithium oralkaline batteries. The alternating or direct current may be provided byalternative energy sources such as wind or solar.

According to one embodiment, the interferometric system is stabilized toaddress vibrational distortions. The system may be stabilized by variousmeans including mechanical, chemically (fluid float or gel pack),computer-assisted system (electronically), or digitally (e.g., via acamera). In some implementations, the systems provided herein allow forpoint of use assays that are stable in various conditions, includingambient temperature and humidity as well as extreme heat, cold andhumidity.

The interferometric systems as provided herein may be equipped with oneor more software packages loaded within. The software may beelectronically connected to the various system components as providedherein. The software may also be electronically integrated with adisplay for viewing by a user. The display may be any variety of displaytypes such as, for example, a LED-backlit LCD. The system may furtherinclude a video display unit, such as a liquid crystal display (“LCD”),an organic light emitting diode (“OLED”), a flat panel display, a solidstate display, or a cathode ray tube (“CRT”).

According to one embodiment, the interferometric system as providedherein may interface with or otherwise communicate with a transmissioncomponent. The transmission component may be in electronic signalcommunication with both the cartridge system and interferometric systemcomponents. The transmission component sends or transmits a signalregarding analyte detection data and quantification data. Thetransmission of such data may include real-time transmission via any ofa number of known communication channels, including packet data networksand in any of a number of forms, including instant message,notifications, emails or texts. Such real-time transmission may be sentto a remote destination via a wireless signal. The wireless signal maytravel via access to the Internet via a surrounding Wi-Fi network. Thewireless signal may also communicate with a remote destination viaBluetooth or other radio frequency transmission. The remote destinationmay be a smart phone, pad, computer, cloud device, or server. The servermay store any data for further analysis and later retrieval. The servermay analyze any incoming data using artificial intelligence learningalgorithms or specialized pathological, physical, or quantum mechanicalexpertise programed into the server and transmit a signal.

According to one embodiment, the transmission component may include awireless data link to a phone line. Alternatively, a wireless data linkto a building Local Area Network may be used. The system may also belinked to Telephone Base Unit (TBU) which is designed to physicallyconnect to a phone jack and to provide 900 MHz wireless communicationsthereby allowing the system to communicate at any time the phone line isavailable.

According to one embodiment, the interferometric system may include alocation means. Such a location means includes one or more geolocationdevice that records and transmits information regarding location. Thelocation means may be in communication with a server, either from a GPSsensor included in the system or a GPS software function capable ofgenerating the location of the system in cooperation with a cellular orother communication network in communication with the system. Accordingto a particular embodiment, the location means such as a geolocationdevice (such as GPS) may be utilized from within its own device or froma mobile phone or similarly collocated device or network to determinethe physical location of the cartridge system.

According to one embodiment, the interferometric system contains ageo-location capability that is activated when a sample is analyzed to“geo-stamp” the sample results for archival purposes. According to oneembodiment, the interferometric system contains a time and datecapability that is activated when a sample is analyzed to time stamp thesample results for archival purposes.

The interferometric systems provided herein may interface with softwarethat can process the signals hitting the detector unit. The cartridgesystem as provided herein may include a storage means for storing data.The storage means is located on or within the cartridge housing orwithin the interferometric system housing. The storage meanscommunicates directly with electronic components of the interferometricsystem. The storage means is readable by the interferometric system.Data may be stored as a visible code or an index number for laterretrieval by a centralized database allowing for updates to the data tobe delivered after the manufacture of the cartridge system. The storagemeans may include memory configured to store data provided herein.

The data retained in the storage means may relate to a variety itemsuseful in the function of the interferometric system. According to aparticular embodiment, the data may provide the overall interferometricsystem or cartridge system status such as whether the cartridge systemwas previously used or is entirely new or un-used. According to aparticular embodiment, the data may provide a cartridge system orinterferometric system identification. Such an identification mayinclude any series of letter, numbers, or a combination thereof. Suchidentification may be readable through a QR code. The identification maybe alternatively memorialized on a sticker located on the cartridgehousing or interferometric system housing. According to one embodiment,the cartridge housing contains a bar code or QR code. According to oneembodiment, the cartridge system contains a bar code or QR code forcalibration or alignment. According to one embodiment, the cartridgesystem contains a bar code or QR code for identification of thecartridge or test assay to be performed. According to one embodiment,the cartridge system contains a bar code or QR code for identificationof the owner and location of where any data generated should betransmitted. A user may scan such a QR code with the interferometricsystem's external camera prior to use to use of the system such thatidentification and transmission may occur (e.g., automatically or uponuser direction).

According to a particular embodiment, the data retained in the storagemeans may provide the number of uses remaining for a multiple-usecartridge system. According to a particular embodiment, the data mayprovide calibration data required by interferometric system to processany raw data into interpretable results. According to a particularembodiment, such data may relate to information about the analyte andany special processing instructions that can be utilized by thecartridge system to customize the procedure for the specific combinationof receptive surface(s) and analyte(s). The interferometric system asprovided herein may include electronic memory to store data via a codeor an index number for later retrieval by a centralized databaseallowing for updates to the data to be delivered after the manufactureof the cartridge system.

The interferometric system may include a memory component such thatoperating instructions for the interferometric system may be stored. Alldata may be stored or archived for later retrieval or downloading onto aworkstation, pad, smartphone or other device. According to oneembodiment, any data obtained from the system provided herein may besubmitted wirelessly to a remote server. The interferometric system mayinclude logic stored in local memory to interpret the raw data andfindings directly, or the system may communicate over a network with aremotely located server to transfer the raw data or findings and requestinterpretation by logic located at the server. The interferometricsystem may be configured to translate information into electricalsignals or data in a predetermined format and to transmit the electricalsignals or data over a wireless (e.g., Bluetooth) or wired connectionwithin the system or to a separate mobile device. The interferometricsystem may perform some or all of any data adjustment necessary, forexample adjustments to the sensed information based on analyte type orage, or may simply pass the data on for transmission to a separatedevice for display or further processing.

The interferometric systems provided herein may include a processor,such as a central processing unit (“CPU”), a graphics processing unit(“GPU”), or both. Moreover, the system can include a main memory and astatic memory that can communicate with each other via a bus.Additionally, the system may include one or more input devices, such asa keyboard, touchpad, tactile button pad, scanner, digital camera oraudio input device, and a cursor control device such as a mouse. Thesystem can include a signal generation device, such as a speaker orremote control, and a network interface device.

According to one embodiment, the interferometric system may includecolor indication means to provide a visible color change to identify aparticular analyte. According to one embodiment, the system may includea reference component that provides secondary confirmation that thesystem is working properly. Such secondary confirmation may include avisual confirmation or analyte reference that is detected and measuredby the detector.

The interferometric system as provided herein may also include atransmitting component. The transmitting component may be in electronicsignal communication with the detector component. The transmittingcomponent sends or transmits a signal regarding analyte detection andquantification data. The transmission of such data may include real-timetransmission via any of a number of known communication channels,including packet data networks and in any of a number of forms,including text messages, email, and so forth. Such real-timetransmission may be sent to a remote destination via a wireless signal.The wireless signal may travel via access to the Internet via asurrounding Wi-Fi network. The wireless signal may also communicate witha remote destination via Bluetooth or other radio frequencytransmission. The remote destination may be a smart phone, pad,computer, cloud device, or server. The server may store any data forfurther analysis and later retrieval. The server may analyze anyincoming data using artificial intelligence learning algorithms orspecialized pathological, physical, or quantum mechanical expertiseprogramed into the server and transmit a signal.

According to one embodiment, the interferometric system includes awireless data link to a phone line. Alternatively, a wireless data linkto a building Local Area Network may be used. The system may also belinked to Telephone Base Unit (TBU) which is designed to physicallyconnect to a phone jack and to provide 900 MHz wireless communicationsthereby allowing the system to communicate at any time the phone line isavailable.

According to one embodiment, the system may also include geolocationinformation in its communications with the server, either from a GPSsensor included in the system or a GPS software function capable ofgenerating the location of the system in cooperation with a cellular orother communication network in communication with the system. Accordingto a particular embodiment, the system may include a geolocation device(such as GPS or RFID) either from within its own device or from a mobilephone or similarly collocated device or network to determine thephysical location of the system.

According to one embodiment, the interferometric system includes anexternal camera. The external camera may be at least partially locatedwithin the interferometric system housing but include a lens exposed tothe exterior of the housing such that the external camera may takephotos and video of a target sample prior to collection (e.g., soil,plant, etc.). The external camera may capture video or images that aidin the identification of an analyte and confirmation of the resultingdata. The external camera may also capture video images that aid inselecting a proper remedial measure. The external camera may capturevideo or images that aid in the identification of a target sample orsource thereof.

The external camera may capture video or images in connection withscanning and identifying a QR code (such as a QR code on an externalsurface of a cartridge housing). When located on an external surface ofthe cartridge housing, the QR code may also aid in identifying ownershipof generated data and transmission of such data to a correct owner.

According to one embodiment, the cartridge system contains ageo-location capability that is activated when a sample is analyzed to“geo-stamp” the sample results for archival purposes. According to oneembodiment, the cartridge system contains a time and date capabilitythat is activated when a sample is analyzed to time stamp the sampleresults for archival purposes. According to one embodiment, thecartridge system includes materials that are biodegradable, or recycledmaterials, to reduce environmental impact. Any used cartridge systemprovided herein may be disposed of in any acceptable manner such as viaa standard biohazard container. According to one embodiment, thecartridge system facilitates cleaning and re-tooling to allow thecartridge system to be replenished and returned to operation.

According to one embodiment, the cartridge system is stabilized toaddress vibrational distortions. The system may be stabilized by variousstabilization means including mechanical (alignment means as providedherein), chemically (fluid float or gel pack), computer-assisted system(electronically), or digitally (e.g., via a camera or digitalprocessing).

Microfluidic System Overview—Single-Use Cartridge System

The single-use cartridge system provided herein includes a microfluidicsystem for communicating or otherwise providing a means for test sampleand buffer to mix thereby resulting in a test sample composition. Themicrofluidic system causes the test sample composition move through thedetection region to allow for detection and analysis of one or moreanalytes. The microfluidic system includes an injection port forintroduction of a test sample. The injection port may optionally includea check valve. The microfluidic system further includes a firstmicrochannel section having a first end attached in communication withthe injection port check valve and a second end in communication with amixing bladder. According to one embodiment, the first microchannelsection contains a filter to remove materials not capable of detectionand quantification. The mixing bladder is sized, shaped and otherwiseconfigured to store buffer. The mixing bladder is sized, shaped andotherwise configured to aid in mixing buffer and test sample to form thetest sample composition. The mixing bladder may be bypassed such thatthe test sample composition may be automatically discharged or allowedto proceed through the microfluidic system. The mixing bladder mayinclude a temperature control means in the form of a metal coil wrappedaround the mixing bladder such that the temperature control means isheated upon introduction of an electric current.

The microfluidic system further includes second microchannel sectionhaving a first end attached in communication with the mixing bladder anda second end attached in communication with a flow cell having at leastone detection microchannel. By including multiple two or more detectionmicrochannels, the cartridge system is particularly suited for highthroughput and improved testing efficiency by being able to detect andquantify analyte in more than one test sample composition.

The microfluidic system further includes at least one pump. Suitablepumps include micropumps such as, but are not limited to, diaphragm,piezoelectric, peristaltic, valveless, capillary, chemically-powered, orlight-powered micropumps. According to an alternative embodiment, themicrofluidic system further includes at least one pump that is a,positive-displacement pump, impulse pump, velocity pump, gravity pump,steam pump, or valve-less pump of any appropriate size. According to asingle-use embodiment of the cartridge system, the cartridge systemcontains at least one pump located within the cartridge housing.According to one embodiment of a single-use cartridge system, the pumpoverlays or otherwise engages or touches the first microchannel section,second microchannel section and mixing bladder.

The microfluidic system of the single-use cartridge system as providedherein may be manufactured and packaged under negative pressure orvacuum sealed. In this manner, the negative pressure allows for a testsample to be pulled in and become self-loading upon introduction of thetest sample. The negative pressure further allows for a test sample tobe pulled in in the microfluidic system to reduce, avoid or eliminatebubble formation upon introduction of the test sample. According to analternative embodiment, the microfluidic system is manufactured andpackaged under a positive pressure. According to either embodiment, themicrofluidic system of a single-use cartridge system may be pre-loadedwith a buffer solution at the time of manufacture. The buffer may becustom designed or designated for a particular analyte detection. Buffersolution that is used (i.e., buffer waste) and resulting test samplecomposition waste may be contained permanently in the single-usecartridge system.

According to one embodiment, the pump can be powered by a battery orelectricity transferred from the testing device. Alternatively, theenergy to power the pump can be mechanically transferred by directforce, electromagnetic induction, magnetic attraction, audio waves, orpiezo electric transfer. According to one embodiment, the cartridgesystem includes at least one pulse dampening component such as aregulator or accumulator or bladder.

Microfluidic System Overview—Multiple-Use Cartridge System

The multiple-use cartridge system provided herein includes amicrofluidic system for communicating or otherwise providing a means fora test sample composition to move through the cartridge system and allowfor detection and analysis of one or more analytes. According to aparticular embodiment, the test sample and test sample composition areair or liquid. An ingress port is located on a front surface of themultiple-use cartridge system. The ingress port is in communication witha first microchannel section having a first end attached incommunication with an ingress port check valve and a second end incommunication with second microchannel section. A filter may be locatedanywhere within the first microchannel section.

The second microchannel section includes a first end in communicationthe first microchannel section and a second end in communication with aflow cell having at least one detection microchannel. The cartridgesystem includes a detection region that accommodates or is otherwiseadapted to receive the chip and flow cell wafer.

The detection microchannel is in communication with a first end of athird microchannel section. The third microchannel section includes aflow electrode to approximate flow rate and is correlated with measuredimpedance. The third microchannel section includes a second end incommunication with the first end of a fourth microchannel. The fourthmicrochannel includes a second end in communication with a check valvewhich, in turn, is in communication with an egress port. The chiputilized in the multiple-use embodiment may be removable from thecartridge system.

The microfluidic system further includes at least one pump. Suitablepumps include micropumps that include, but are not limited to,diaphragm, piezoelectric, peristaltic, valveless, capillary,chemically-powered, or light-powered micropumps. According to analternative embodiment, the microfluidic system further includes atleast one pump that is a positive-displacement pump, impulse pump,velocity pump, gravity pump, steam pump, or valve-less pump of anyappropriate size. According to one multiple-use embodiment of thecartridge system, the cartridge system contains at least one pumplocated outside (external to) the cartridge housing but in communicationwith the microfluidic system. The external pump may be utilized to movetest sample composition through the microfluidic system to aid inremoval of air or bubble that may be present in a liquid test samplecomposition prior to use. According to one embodiment, the cartridgesystem contains at least one pump dampening device.

All of the cartridge systems provided herein may utilize the pump tomanipulate the communication of test sample composition throughout themicrofluidic system. According to one embodiment, the pump causes orotherwise aids movement of test sample composition through themicrochannels as well as the mixing bladder, when present.

Handheld Interferometric System—Exemplary Embodiment

FIG. 1 illustrates a perspective view of one embodiment of a portableinterferometric system 100 as provided herein. The portableinterferometric system 100 may include a display unit 102. The portableinterferometric system 100 may include a housing 104 adapted to fitwithin a user's hand.

FIG. 2A illustrates a front view of one embodiment of a portableinterferometric system 100 that utilizes the cartridge systems providedherein. The housing 104 includes an external front surface 106 definingan opening 108 adapted to receive the cartridge system provided herein.The opening 108 aids in the alignment and proper position of thecartridge system as provided herein within the handheld interferometricsystem 100. The opening 108 may optionally include a flap 110 thatshields or covers the opening 108 when the cartridge is not inserted.The flap 110 may be hinged on any side so as to aid in the movement ofthe flap 110 from a first, closed position to a second, open positionupon insertion of the cartridge system.

FIG. 2B illustrates a rear view of one embodiment of a portableinterferometric system 100 as provided herein. The housing 104 isadapted to include USB Type C 112, USB Type A 114, data or phone lineinlet 116, power cord inlet 118, power switch 120, and external cameraor other light sensitive device 122.

Chip Overview

As previously noted, the cartridge systems provided herein furtherincludes a detection region. This detection region accommodates or isotherwise adapted to receive an interferometric chip and flow cellwafer. The flow cell wafer includes at least one detection microchannel.The flow cell wafer is located directly above the chip. The detectionmicrochannel may be etched onto a flow cell wafer having a substantiallytransparent or clear panel or window. The detection microchannel alignswith each waveguide channel in the chip.

In use, a light signal may be emitted from a light unit located in theinterferometric system. The light enters flow through entry gradients inthe chip and through one or more waveguide channels. According to aparticular embodiment, there may be two or more waveguides channels todetermine the presence of a separate analyte that each of the individualwaveguides channels alone would not have been able to identify alone.The evanescent field is created when the light illuminates the waveguidechannel. The light signal is then directed by exit gradients to adetector unit such as a camera unit. The detector unit is configured toreceive the light signal and detect an analyte present in a test samplecomposition. The chip may further include a reference waveguide channel.

A sensing layer is adhered to a top side of one or more waveguidechannels. According to a particular embodiment, the sensing layer mayinclude one or more antigens or antibodies that are immobilized on thewaveguide channel surface to sense the antigen-specific antibody orantigen, respectively. According to another embodiment, the sensinglayer may include envelope, membrane, nucleocapsid N-proteins ordifferent domains of one of the proteins in a natural or artificialvirus used to delivery interfering RNA (RNAi) as a treatment.

According to a particular embodiment, the sensing layer may include amolecularly imprinted polymer. The molecularly imprinted polymer leavescavities in the polymer matrix with an affinity for a particular analytesuch as an antibiotic.

According to a particular embodiment, the sensing layer may include aDNA microarray of DNA probes. Each probe may be specific for a pathogen(i.e., bacterial species) and when the probe hybridizes with a sample,the sample/probe complex fluoresces in UV light or may be detected viainterferometric analysis.

According to one embodiment, the sensing layer may utilize immunoassayson top of the waveguide channels for detection of one or more analytes.According to one embodiment, the system may include, or function basedon, an enzyme-linked immunosorbent assay (ELISA) or other ligand bindingassays that detect analytes in target samples. According to oneembodiment, the sensing layer may utilize one or more polypeptides,nucleic acids, antibodies, carbohydrates, lipids, receptors, or ligandsof receptors, fragments thereof, and combinations thereof. According toone such embodiment, the sensing layer is configured to include one ormore antibodies as well as one or more immunoglobulins to aid in theindication of the stage of analyte infection. Suitable immunoglobulinsinclude IgG, IgM, IgA, IgE and IgD.

Flow Cell Overview

Each of the cartridge systems described herein include a flow cellhaving at least one detection microchannel adapted to communicate withone or more test sample compositions flowing through a waveguide channelin a chip beneath the flow cell. According to one embodiment, thecartridge systems may include at least two, at least three, or at leastfour detection microchannels with each detection microchannel adapted tocommunicate one or more test sample composition allowing detection ofthe same or different analytes.

Each detection microchannel is located on or within a flow cellmanufactured from a wafer. The at least one detection microchannel maybe etched, molded or otherwise engraved into one side of the flow cellwafer. Thus, the at least one detection microchannel may be shaped as aconcave path as a result of the etching or molding within the flow cellwafer.

The flow cell wafer is oriented above the chip during use such that thedetection microchannel may be orientated or otherwise laid out invariety of flow patterns above the waveguide channels. The detectionmicrochannel may be laid out, for example, in a simple half loop flowpattern, serial flow pattern, or in a serpentine flow pattern. Theserpentine flow pattern is particularly suited for embodiments wherethere are multiple waveguide channels that are arranged in a parallelarrangement. By utilizing the serpentine flow pattern, the testcomposition flows consistently over the waveguide channels withoutvarying flow dynamics.

Chip, Flow Cell and Optical Assembly—Exemplary Embodiment

FIG. 3A illustrates a cross-sectional view of an optical detectionregion 200 of a cartridge system. A chip (or substrate) 202 includes awaveguide channel 204 attached to a surface 205 (such as the illustratedtop surface) of the chip 202. An evanescent field 206 is located abovethe waveguide channel 204. A sensing layer 208 is adhered to a top sideof the waveguide channel 204. As illustrated, antibodies 210 are shownthat may bind or otherwise immobilized to the sensing layer 208,however, the sensing layer 208 may be adapted to bind any variety ofanalytes. As such, adjusting or otherwise modifying the sensing layer208 allows for the cartridge system to be utilized for multipledifferent types of analytes without having to modify the cartridgesystem or and surrounding interferometric system components. In generaluse, an light signal (e.g., laser beam) illuminates the waveguidechannel 204 creating the evanescent field 206 that encompasses thesensing layer 208. Binding of an analyte impacts the effective index ofrefraction of the waveguide channel 204.

A bottom view of an exemplary flow cell 300 is illustrated in FIG. 3B.At least one detection microchannel 302 is located on or within a flowcell 300 manufactured from a transparent wafer. The at least onedetection microchannel 302 may be etched, molded or otherwise engravedinto one side of the flow cell wafer 304. Thus, the at least onedetection microchannel 302 may be shaped as a concave path as a resultedof the etching or molding within the flow cell wafer 304. The flow cellwafer 304 may be manufactured a material such as opaque plastic, orother suitable material. The flow cell wafer 304 may optionally becoated with an anti-reflection composition.

The movement of an light signal 308 (series of arrows) through a chip310 is illustrated in FIG. 3C. The light signal 308 moves from a lightunit 312, such as a laser unit, through a plurality of entry gradients314 and through one or more waveguide channels 316. Each channelincludes a pair of waveguides (321, 323). One of the pair of waveguides321 is coated with a sensing layer 208 (as indicated by shading in FIG.3C). The other one of the pair of waveguides 323 is not coated with thesensing layer 208 (serving as a reference). The combination of the lightfrom each in the pair of waveguides (312, 323) create an interferencepattern which is illuminated on detector unit 320.

According to a particular embodiment, the two or more waveguideschannels 316 are utilized that are able to determine the presence of ananalyte that each of the individual waveguides channels 316 alone wouldnot have been able to identify alone. The light signal 308 is thendirected by exit gradients 318 to a detector unit 320 such as a cameraunit. The detector unit 320 is configured to receive the light signal308 and detect any analyte present in a target sample compositionflowing through the detection microchannel 302 (see FIG. 3B).

The chip 310 includes a combination of substrate 202 (see FIG. 3A),waveguide channel (see FIG. 3A part 204 and FIG. 3C part 316) andsensitive layer 208 (see FIG. 3A). The flow cell 300 is oriented abovethe top surface 205 of the chip 310 during use such that the detectionmicrochannel 302 may be orientated or otherwise laid out in variety offlow patterns above the waveguide channels 316. The detectionmicrochannel 302 may be laid out, for example, in a simple half loopflow pattern, serial flow pattern, or in a serpentine flow pattern asillustrated in FIG. 3B. The serpentine flow pattern is particularlysuited for embodiments where there are multiple waveguide channels 316that are arranged in a parallel arrangement (see FIG. 3C). By utilizingthe serpentine flow pattern, the test composition flows consistentlyover the waveguide channels 316 without varying flow dynamics.

The light signal passes through each waveguide channel as illustrated inFIG. 3C, may combine thereby forming diffraction patterns on thedetector unit. The interaction of the analyte 210 (see FIG. 3A) and thesensing layer 208 changes the index of refraction of light in thewaveguide channel per Equation 1. The diffraction pattern is moved whichis detected by the detector unit. The detector unit as provided hereinmay be in electronic communication with video processing software. Anydiffraction pattern movement may be reported in radians of shift. Theprocessing software may record this shift as a positive result. The rateof change in radians that happens as testing is conducted may beproportional to the concentration of the analyte.

FIG. 4 illustrates a side view of an exemplary embodiment of an opticalassembly unit 400 that can be found in the handheld interferometricsystems described herein (such as in FIGS. 1-2 ). The optical assemblyunit 400 includes an light unit 402 aligned in an light unit housing404. The optical assembly unit 400 includes a detector unit 406, such asa camera unit, aligned in a camera unit housing 408.

FIG. 5A illustrates a cross-sectional view of the optical assembly unit400 of FIG. 4 . The light unit 402 is situated at an angle relative tothe shutter flap element 420. The shutter flap element 420 is adapted toslide open and shut under tension from a shutter spring 422. The shutterflap element 420 is illustrated in a first, closed position with nocartridge system inserted. The shutter flap element 420 includes andupper control arm 423 that is located within a rail portion 425.

A complimentary communication means 424 extends downward so as to makeelectronic contact with electronic communications means located on thecartridge housing (see FIGS. 6, 8A and 9A). The complimentarycommunication means 424 may be metal contacts such that, upon insertion,the metal contacts on the exterior surface of the cartridge housingtouch and establish electronic communication between the cartridgesystem and the remaining components of the interferometric system (e.g.,light unit, camera unit, etc.). The complimentary communication means424, as illustrated, include one or more substantially pointed or “V”shaped so as to push down into or otherwise contact the cartridgehousing metal contacts. The number of complimentary communication means424 may match and align with the number of metal contacts on theexterior surface of the cartridge housing.

At least one downward cantilever bias spring 426 may be located withinthe optical assembly unit 400 such that, upon insertion of the cartridgethrough the interferometric system housing opening, the downwardcantilever bias spring 426 pushes against a top side of the cartridgehousing thereby forcing the cartridge housing against an opposite sideor bottom portion or surface 428 of the cartridge recess 430 resultingin proper alignment along a vertical plane (see FIGS. 5A, 5B, 5C and 6).

The light unit 402 is optionally adjustable along various planes foroptimal light signal 432 emission. As illustrated, the signal 432 isshown to be emitted and focused by at least one lens 433. A camera unit406 is situated at an angle relative to the shutter flap element 420 soas to receive the light signal 432 upon exit from the cartridge (seeFIG. 6 ).

A first roll adjustment screw 434 and second roll adjustment screw 436are located on opposing sides of the light unit 402 for adjusting rollof the light unit 402. A first upward adjustment screw 438 and secondupward adjustment screw 440 are located in a parallel manner on eachside the light unit 402 for adjusting the light unit 402 towards thecartridge system (i.e., substantially upward). An angle of incidencescrew 442 is located against the light unit 402 to allow for adjustmentsto the angle of incidence for proper coupling angle. A translation screw444 is located direct communication with the light unit 402 to adjusttranslation in the X axis. A spring element 446 maintains the positionof the light unit 402 against the light unite 402 by assisting theadjustment screws (432, 436), incidence screw 442 and translation screw444.

With specific regard to FIGS. 5A, 5B, and 5C, the bottom portion 428 ofthe cartridge recess 430 further includes alignment means that includesat least one rail portion 425 for engaging both male key portions on thecartridge housing (see 824, 826 of FIG. 8A; see 920, 922 of FIG. 9A).The bottom portion or surface 428 of the cartridge recess 430 includes afirst raised surface 421A and second raised surface 421B. A shutterupper control arm 423 is located within the rail portion 425. The railportion 425 includes a first rail wing 427 and second rail wing 429adapted to receive and engage the male key portions (see 824, 826 ofFIG. 8A; see 920, 922 of FIG. 9A). By including such alignment means,the cartridge systems provided here may only engage in a certain mannerthereby preventing incorrect insertion and provided proper optical andmicrofluidic alignment.

FIG. 6 illustrates a cross-sectional view of the optical assembly 400 ofFIG. 5A with one embodiment of a cartridge system 800 inserted in theoptical assembly 400. As illustrated, the shutter flap element 420 ispushed backwards upon insertion of the cartridge system 800. While notshown, the shutter spring 422 is compressed backwards. The shutter flapelement 420 moves along a track system 450 having a stationary male rail452 on which a female rail portion 454 slides from a first, closedposition with no cartridge system 800 inserted to a second, openposition as illustrated in FIG. 6 upon cartridge system 800 insertion.

FIG. 6 further illustrates positioning of the cartridge system 800 inthe optical assembly 400. The cartridge system 800 includes aninterferometric chip 832 positioned below the flow cell wafer 888. Thecartridge system 800 includes storage means 807 as provided hereinpositioned within the cartridge housing 802. While the cartridge system800 is illustrated as a single-use system, the alignment and positioningof the single-use cartridge assembly may also apply to the multiple-usecartridge systems provided herein (e.g., see FIGS. 9A-9F).

FIG. 7 illustrates a top view of the optical assembly unit 400 of FIG.5A with one embodiment of a cartridge system 800 inserted in the opticalassembly unit 400. The cartridge system 800, as illustrated, is asingle-use system, however, a multiple-use system may be inserted in thesame manner within the interferometric system. The cartridge system 800includes a cartridge housing 802 having a top surface 805. The opticalassembly unit 400, as illustrated, includes a plurality of cantileverbias springs 426. The optical assembly unit 400 further includes atleast one side bias spring 460 such that, upon insertion of thecartridge system 800, the side bias spring 460 pushes against onehorizontal side 860 of the cartridge housing thereby forcing thecartridge housing 802 into proper alignment along a horizontal plane.

Cartridge System Overview

The cartridge systems provided herein includes a cartridge housing. Thecartridge housing may be manufactured from any polymer suitable forsingle or multiple-use. The cartridge may be manufactured according to avariety of additive processing techniques such as 3-D printing. Thecartridge may be manufactured via traditional techniques such asinjection molding. The polymer may include a coefficient of expansionsuch that the housing does not expand or contract in a manner that woulddisrupt alignment of any microfluidic or detection components describedherein when the cartridge is exposed to heat or cold environmentalconditions.

The cartridge housing may include a light prevention means to aid inreducing, preventing or eliminating ambient, outside light frominterfering the detection of one or more analytes. The light preventionmeans may include colored cartridge housing (e.g., black colored) thatis color dyed or coated during manufacture. According to one embodiment,a dye may be introduced to the polymer to provide a specific color to aregion of or the entire cartridge housing. Suitable colors include anycolor that aids in reducing, preventing or eliminating ambient, outsidelight from interfering the detection of one or more analytes.

The cartridge systems provided herein further includes a detectionregion. This detection region accommodates or is otherwise adapted toreceive an interferometric chip and flow cell wafer. The flow cell waferincludes at least one detection microchannel. The flow cell wafer islocated directly above the chip. The detection microchannel may beetched onto a flow cell wafer having a substantially transparent orclear panel or window. The flow cell wafer, the chip or both the flowcell and chip may be coated with a substance that reduces or eliminatesfogging or condensation. According to one embodiment, the chip may beheated to reduce or elimination fogging or condensation.

The cartridge systems provided herein are configured or otherwiseadapted or designed to easily insert and instantly align within aninterferometric system such as, for example, a hand-held interferometricsystem. By being configured to allow for instant alignment, no furtheradjustment is required by a user to align any microfluidic componentsand any internal detection-related components such as the laser, chipwith waveguides and exposed channels in a detection region of thecartridge, optical detector and any other focus-related components inthe interferometric system.

The cartridge housing includes dimensions that are complimentary in sizeand shape to the size and shape to an internal surface defining a recesswithin an interferometric system. As provided and illustrated in thenon-limiting examples herein, the cartridge housing may be generallyrectangular in overall shape.

According to one embodiment, the cartridge system may be inserted andremoved automatically. According to one embodiment, the cartridgehousing contains a bar code or QR code. According to one embodiment, thecartridge system contains a bar code or QR code for calibration oralignment.

To aid in alignment, the cartridge housing includes an alignment meanson an external surface of the cartridge housing. The alignment meansmany take a variety of forms that assure instant alignment of anymicrofluidic components and any internal detection-related componentsupon insertion of the cartridge within the interferometric system. Thealignment means also aids in the prevention of incorrect orientationassertion within the interferometric system and allows for insertiononly after proper alignment is attained. The alignment means furtherallows for the cartridge system to be stabilized to address vibrationaldistortions.

The alignment means may include at least one male key portion forengaging and securing within a corresponding female rail located in theinterferometric system. The male key portion may be disposed on thebottom surface of the cartridge housing, however, the male key portionmay be located on any exterior surface of the cartridge housing. Othersuitable alignment means include one or more microswitches or sensingdevices that guide the cartridge housing to assure proper alignment.

According to a particular embodiment, the cartridge housing includes atop portion and a bottom portion based on the orientation of insertionin an interferometric system. The top portion may include a top surfacedefining at least one through hole on at least one external surface ofeither the top portion or bottom portion. The at least one through holeis adapted to receive a removable fastening means for securing the topportion and bottom portion together. Suitable fastening means includescrews or other suitable fastener that may be removed. By allowing thetop portion and bottom portion of the cartridge housing to be separatedand re-attached, a user may open the cartridge housing to allow forcleaning as well as replacement of the chip.

The cartridge system as provided herein may include a temperaturecontrol means to control temperature as well as humidity. The cartridgesystem as provided herein may include a temperature control means tocontrol test sample composition temperature. By controlling temperatureand humidity around the cartridge system, the interferometric system canprovide more repeatable, precise results. According to one embodiment,the cartridge system contains heating capability to facilitateconsistent measurement and operation in cold temperatures. Bycontrolling temperature and humidity around the cartridge system,fogging or condensation that causes interference in the detection regionof the cartridge system is reduced or otherwise eliminated. Thetemperature control means may be located on or within the cartridgehousing. According to a single-use cartridge system embodiment, thetemperature control means is located on or around the mixing bladder ofthe microfluidic fluid system described herein. The temperature controlmeans may be located on an exterior surface of the cartridge housing.One suitable temperature control means includes a metal coil that isheated upon introduction of an electric current. Another suitabletemperature control means includes one or more warming bands or Peltierdevices that can provide heating or cooling.

Each of the cartridge systems described herein include a flow cellhaving at least one detection microchannel adapted to communicate withone or more test sample compositions flowing through a waveguide channelin a chip beneath the flow cell. According to one embodiment, thecartridge systems may include at least two detection microchannels witheach detection microchannel adapted to communicate one or more testsample composition allowing detection of the same or different analytes.According to one embodiment, cartridge system includes a flow cellhaving at least three detection microchannels with each detectionmicrochannel adapted to communicate one or more test sample compositionallowing detection of the same or different analytes. According to oneembodiment, cartridge system includes a flow cell having at least fourdetection microchannels with each detection microchannel adapted tocommunicate one or more test sample composition allowing detection ofthe same or different analytes.

Cartridge System—Exemplary Embodiments

An exemplary embodiment of a single-use cartridge system 800 isillustrated in FIGS. 8A-F. A top view of a cartridge system 800 isprovided in FIG. 8A. The cartridge system 800 includes a cartridgehousing 802 as described herein. The housing 802 includes a top portion804 (see FIG. 8C) having a top surface 805. The top surface 805 includesfour heat stake posts 808 for joining the top portion 804 of thecartridge housing 802 to a bottom portion 810 (See FIG. 8C) of thecartridge housing 802. By utilizing heat stake posts 808, the topportion 804 may be permanently joined to a bottom portion 810 of thecartridge housing 802. The top surface 805 includes an injection port812 for introduction of a test sample.

The cartridge housing 802 further includes an electronic communicationmeans 816 located on a second external surface 818 that is on adifferent horizontal plane from the top surface 805. The electroniccommunication means 816 as illustrated includes a plurality of metalcontacts.

The cartridge system further includes a vent port 820. The vent port 820allows for any air in the microfluidic system 870 (see FIG. 8F), such asin the form of bubbles, to exit. The vent port 820 may include a ventcover 821 over the vent port 820. The vent cover 821 may be fabricatedfrom a material that repels liquid while allowing air or vapor to passthrough such as, for example, expanded polytetrafluoroethylene(commercially available as Gore-Tex®. The vent cover 821 allows for airpurging from the cartridge system 800 but will not allow fluid to passthrough such as when a vacuum is applied to prime the microfluidicsystem 870. In this way, bubble formation in a liquid test samplecomposition is removed or otherwise avoided. The top surface 805 alsoincludes two port seals 822. The port seals 822 may be made from rubberand provides sealing of the microfluidic system 870 within the cartridgesystem 800.

FIG. 8B illustrates a view of the bottom surface 823 of one embodimentof a single-use cartridge system 800. The bottom surface 823 includes afirst male key portion 824 and a second male key portion 826. The malekeying portions (824, 826) engage with a corresponding rail portion(425—See FIGS. 5A, 5B and 5C) located in the cartridge recess 430 of theoptical assembly 400. The bottom surface 823 further defines a firstdetent 828 and a second detent 830. The detents (828, 830) engage withor otherwise receive a corresponding first raised surface and a secondraised surface (421A, 421B) inside the cartridge recess 430 of theoptical assembly 400 (see FIGS. 5A, 5B and 5C). When engaged with thefirst detent 828 and second detent 830, the first raised surface andsecond raised surface (421A, 421B) aid in securing the cartridge system800 within the cartridge recess 430.

The chip 832 is substantially transparent and allows the light signal toenter, interact with one or more waveguides channels (See FIG. 3C) andallow for binding of analyte flowing within the at least one detectionmicrochannel 834 within the flow cell wafer 888.

The bottom surface 823 further defines a light inlet slot 836. The lightinlet slot 836 allows for an light signal to enter the cartridge system800. Particularly, the light inlet slot 836 allows for an light signalto enter the chip 832 and for the light signal to move through anywaveguide channels (not shown; see e.g., part 316 of FIG. 3C) in thechip 832 while interacting with analytes in the at least one detectionmicrochannel 834 before the light signal is deflected by one or moregratings (not shown) down to the detector unit 406 (see e.g., FIGS. 3Cand 6 ).

FIG. 8C illustrates a view of the back surface 840 of the cartridgehousing 802 of a single-use cartridge system 800. The cartridge housing802 includes a top portion 804 and a bottom portion 810. The male keyingportions (824, 826) are shown extending from the bottom portion 810 ofthe cartridge housing 802.

FIG. 8D illustrates a view of the front surface 850 of the cartridgehousing 802 of a single-use cartridge system 800. The male keyingportions (824, 826) are shown extending from the bottom portion 810 ofthe cartridge housing 802.

FIG. 8E illustrates a view of one side surface 860 of the cartridgehousing 802 of a single-use cartridge system 800, the opposing sidebeing a mirror image.

FIG. 8F illustrates a cross-section view downward of a single-usecartridge system 800 along the horizontal line of FIG. 8E. The cartridgesystem 800 includes a detection region 831 that accommodates or isotherwise adapted to receive a chip 832 and flow cell wafer 888. Thesingle-use cartridge system 800 includes a microfluidic system 870 forcommunicating or otherwise providing a means for a test samplecomposition to move through the cartridge system 800 and allow fordetection and analysis of one or more analytes. The microfluidic system870 includes an injection port 812 for introduction of a test sample.The injection port may 812 optionally include a check valve 872. Themicrofluidic system 870 further includes a first microchannel section874 having a first end 876 attached in communication with the injectionport check valve 872 and a second end 878 in communication with a mixingbladder 880. A filter 877 may be located anywhere within the firstmicrochannel section 874. The microfluidic system 870 also includes avent port 820 within the first microchannel section 874 between thefirst end 876 and second end 878. The mixing bladder 880 includes atemperature control means 881 in the form of a metal coil wrapped aroundthe mixing bladder 880 such that the temperature control means 881 isheated upon introduction of an electric current.

The microfluidic system 870 further includes second microchannel section882 having a first end 884 attached in communication with the mixingbladder 880 and a second end 886 attached in communication with a flowcell wafer 888 having at least one detection microchannel 834.

The microfluidic system 870 further includes third microchannel section890 having a first end 892 attached in communication with at least onedetection microchannel 834 and a second end 894 in communication back tothe mixing bladder 880 so as to form a closed loop.

The microfluidic system 870 further includes at least one micropump 898.The micropump 898, as illustrated, is a piezoelectric pump that overlaysor otherwise engages or touches one or more of the first microchannelsection 874, second microchannel section 882, third microchannel section890 and mixing bladder 880. The micropump 898 manipulates thecommunication of test sample composition throughout the microfluidicsystem 870.

The single-use cartridge system 800 may further include a transmissioncomponent 897 as provided herein. The single-use cartridge system 800may further include a location means 899 as provided herein.

An exemplary embodiment of a multiple-use cartridge system 900 isillustrated in FIGS. 9A-F.

A top view of an embodiment of a multi-use cartridge system 900 isprovided in FIG. 9A. The cartridge system 900 includes a cartridgehousing 902 as described herein. The housing 902 includes a top portion904 (see FIG. 9C) having a top surface 905. As illustrated, the topsurface 905 includes four top through holes 908A. The top through holes908A are adapted (e.g., threaded) to receive a removable fastening means(not shown) for securing the top portion 904 to a bottom portion 910(see FIG. 9C). The top surface also includes two sealing holes 908B thatallow for sealing of the chip 936 to the cartridge housing 902.

The cartridge housing 902 further includes an electronic communicationmeans 916 located on a second external surface 918 that is on adifferent horizontal plane from the top surface 905. The electroniccommunication means 916 as illustrated includes a plurality of metalcontacts. The top surface 905 also includes two port seals 919 and twoseal plugs (924, 926).

FIG. 9B illustrates a view of the bottom surface 923 of a multiple-usecartridge system 900. The bottom surface 923 includes a first male keyportion 920 and a second male key portion 922. The male keying portions(920, 922) engage with a corresponding rail portion (425—See FIGS. 5A,5B and 5C) located in the interferometric system. The bottom surface 923further defines a first detent 928 and a second detent 930. The detents(928, 930) engage with or otherwise receive a corresponding first raisedsurface and a second raised surface (421A, 421B) inside the cartridgerecess 430 of the optical assembly 400 (see FIGS. 5A, 5B and 5C). Whenengaged with the first detent 928 and second detent 930, the firstraised surface and second raised surface (421A, 421B) aid in securingthe cartridge system 900 within the cartridge recess 430.

The bottom surface further includes bottom through holes 908C that alignand correspond to the four top through holes 908A. The bottom throughholes 908C may be adapted (e.g., threaded) to receive a removablefastening means (not shown) for securing the top portion 904 to a bottomportion 910 (see FIG. 9C).

The bottom surface 923 further defines a light inlet slot 934. The lightinlet slot 934 allows for an light signal to enter the cartridge system900. Particularly, the light inlet slot 934 allows for an light signalto enter the chip 936 and for the light signal to move through anywaveguides in the chip 936 while interacting with analytes in the atleast one detection microchannel 994 (see FIG. 9F) before the lightsignal is deflected by one or more gratings (not shown) down to thedetector unit 406 (see FIG. 6 ).

FIG. 9C illustrates a view of the back surface 940 of one embodiment ofa multiple-use cartridge system 900. The housing includes a top portion904 that is optionally removable from a bottom portion 910. The malekeying portions (920, 922) are shown extending from the bottom portion910 of the cartridge housing 902.

FIG. 9D illustrates a view of the front surface 950 of one embodiment ofa multiple-use cartridge system 900. FIG. 9E illustrates view of oneside surface 960 of one embodiment of a single-use cartridge system 900,the opposite side being a mirror image.

FIG. 9F illustrates a cross-section view downward of a multiple-usecartridge system 900 along the horizontal line of FIG. 9E. The cartridgesystem 900 a storage means 907 as provided herein positioned within thecartridge housing 902. The multiple-use cartridge system 900 includes amicrofluidic system 970 for communicating or otherwise providing a meansfor a test sample composition to move through the cartridge system 900and allow for detection and analysis of one or more analytes. An ingressport 972 is located on a front surface 950 (see FIG. 9D) of themultiple-use cartridge system 900. The ingress port 972 is incommunication with a first microchannel section 974 having a first end976 attached in communication with an ingress port check valve 973 and asecond end 978 in communication with second microchannel section 979. Afilter 977 may be located anywhere within the first microchannel section974. A sample electrode 980 and reference electrode 982 are in contactwith the second microchannel section 979. Impedance may be measuredbetween the sample electrode 980 and reference electrode 982 to confirmthe presence of test sample composition.

A valve test structure connection 984 is in communication with any testsample composition in the microfluidic system 970. The valve teststructure connection 984 may be fabricated from nitinol shape memoryalloy and aids in the movement of test sample composition into thecartridge system 900.

The second microchannel section 979 includes a first end 988 incommunication the first microchannel section 974 and a second end 990 incommunication with a flow cell 992 having at least one detectionmicrochannel 994. The cartridge system 900 includes a detection region993 that accommodates or is otherwise adapted to receive the chip 936and flow cell 992. The chip 936 is substantially transparent and allowsthe light signal to enter, interact with one or more waveguides channels(not shown; see e.g., part 316 of FIG. 3C) and allow for binding ofanalyte flowing within the at least one detection microchannel 994within the flow cell 992.

The detection microchannel 994 is in communication with a first end 996of a third microchannel section 998. The third microchannel section 998includes a flow electrode 1000 to approximate flow rate and iscorrelated with measured impedance. The third microchannel section 998includes a second end 1002 in communication with the first end 1004 of afourth microchannel 1006. The fourth microchannel 1006 includes a secondend 1008 in communication with a check valve 1010 which, in turn, is incommunication with an egress port 1012. The sample electrode 980,reference electrode 982, and flow electrode 1000 are each fabricatedfrom inert nitinol or other corrosion-resistant conductive material.

The multiple-use cartridge system 900 may further include a transmissioncomponent 1014 as provided herein. The multiple-use cartridge system 900may further include a location means 1016 as provided herein.

An exemplary embodiment of an alternative single-use cartridge system1100 is illustrated in FIG. 10 . According to the illustratedembodiment, the cartridge system 1100 includes a connection mechanism1102 (or snap-in rod) having opposing ends (1104, 1106) extending fromthe housing 1108. The connection mechanism 1102 aids in securing andinterfacing the cartridge system 1100 with an interferometric system.Rising from the housing 1108, are an injection ports 1110 A-D and outletports 1120 A-D. The injection ports 1110 A-D may be utilized forintroducing a test sample, buffer or a test sample composition. Thecartridge system includes four independent detection microchannel portsthat are independently in communication with a corresponding detectionmicrochannel (not shown) within a flow cell (not shown). Buffer may bepre-loaded in the flow cell. Any test sample composition waste may becollected from the outlet ports 1120 A-D.

Aquatic Applications

By being mobile and utilized near the aquatic environment in question, auser may receive results in an efficient manner and any care or remedialmeasure decisions may be implemented immediately. The interferometricsystems provided herein provide a major technical advancement in thefight to diagnose and track pathogens that are the cause of rising,recurring or endemic diseases as well as invading species of pathogen inan aquatic environment. The systems provided herein provide a means toindicate and otherwise aid in the control of disease surveillance,invasive species of pathogen and pandemic or widespread outbreakcontrol. The systems provided herein also provide a means to assesswater quality as well as serve as a microbe-based monitoring system toprovide an early warning system for detection of unwanted pathogens inan aquatic environment.

According to a particular embodiment, the systems provided herein may beutilized to detect and quantify levels of pesticide in an aquaticenvironment. By providing detection and quantification data in anefficient manner within the aquatic environment, application and controlrate of pesticide may be monitored, adjusted and otherwise controlled.According to such an embodiment, the system will detect and quantifypesticide at the parts per million (ppm) level. According to anotherembodiment, the system will detect and quantify pesticide at the partsper billion (ppb) level. According to another embodiment, the systemwill detect and quantify pesticide at the parts per trillion (ppt)level.

According to a particular embodiment, the systems provided herein may beutilized to detect and quantify levels of an aquatic herbicide (e.g.,2,4-D (2,4-dichlorophenoxyacetic acid) and flumioxazin(2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2H-1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)-dione))in an aquatic environment. By providing detection and quantificationdata in an efficient manner within the aquatic environment, applicationand control rate of herbicide may be monitored, adjusted and otherwisecontrolled. Such control increases the efficiency of aquatic vegetationmanagement. Such vegetation may include water hemp, duck weed or algae.

According to one embodiment, the system may be utilized to detect andquantify analytes from any vessel or container that may come internallyin contact with an analyte such as a chemical contaminant. The system asprovided herein may be placed in fluid communication with a vessel so asto detect and quantify analytes in real time. Fluid communication may beestablished via a tube or other conduit that allows any fluid containingthe fluid containing the aquatic test sample composition to come incontact with, or flow through, the system as provided herein.

According to one particular embodiment, the interferometric systemprovided here may be utilized in connection with or otherwise equippedto a mobile vehicle. Suitable mobile vehicles include, but are notlimited to, unmanned aerial vehicles (UAV), unmanned ground vehicles(UGV), drones, manned aircraft, and manned vehicles.

Methods of Detection and Quantification

FIG. 11 illustrates a method 1200 of detecting and quantifying the levelof analyte in an aquatic test sample composition. The method includesthe step of collecting 1202 or otherwise obtaining a target samplehaving one or more analytes. In different embodiments, the target samplemay be taken from the appropriate target depending on the location andenvironment.

According to one embodiment, the method further includes the optionalstep of entering 1204 a user identifier (ID) in the system.Additionally, an identification number associated with the sample,analyte or interest or a combination thereof may be entered. Thecartridge system utilized may be equipped with a label or stickercarrying identifying such information. The label or sticker may includea QR code including such information. The label or sticker may beremoved prior to use. Identifying information may include metadata suchas time, GPS data, or other data generated by the interferometricsystem.

According to one embodiment, the method further includes the step ofintroducing the target sample to the interferometric system 1206.According to one embodiment, target sample is introduced to thecartridge by a separate device such as a syringe or pump. According toone embodiment, target sample is introduced by an injection device.According to one embodiment, the injection device may be permanentlyattached to the cartridge system. According to one embodiment, theinjection device is a pipette. According to one embodiment, theinjection device is a syringe. According to one embodiment, theinjection device is a lance, pipette or capillary tube. When utilizing amultiple-use cartridge system, the cartridge system may be fitted to atube or other transfer mechanism to allow the sample to be continuouslytaken from a large amount of fluid that is being monitored.

According to one embodiment, the method further includes the step ofmixing 1208 the target sample with a buffer solution to form a testsample composition. In a multiple-use cartridge system, such a step mayoccur prior to the test sample composition being introduced to thecartridge system. In a single-use cartridge system, such a step mayoccur in the mixing bladder with the assistance of a pump.

The method of detecting and quantifying the level of analyte in a sampleincludes initiating waveguide interferometry 1210 on the test samplecomposition. Such a step may include initiating movement of the lightsignal through the cartridge system as provided herein and receiving thelight signal within the detector unit. Any changes in an interferencepattern are representative of analyte in the test sample composition.Particularly, such changes in an interference pattern generate datarelated to one or more analyte in the test sample composition. Accordingto one embodiment, the step of initiating 1210 waveguide interferometryon the test sample composition includes the step of correlating datafrom the phase shift with calibration data to obtain data related toanalyte identity, analyte concentration, or a combination thereof.

According to one embodiment, the method further includes the step ofprocessing 1212 any data resulting from changes in the interferencepattern. Such changes in interference pattern may be processed andotherwise translated to indicate the presence and amount of an analytein a test sample composition. Processing may be assisted by software,processing units, processor, servers, or other component suitable forprocessing. The step of processing data may further include storing suchdata in storage means as provided herein.

According to one embodiment, the method further includes the step oftransmitting a data signal 1214. The signal may result in the display ofdata on the system. The step of transmitting data may include displayingthe analyte levels via projecting any real time data on a screen asdescribed herein. The step of transmitting data may include transmittingany obtained data to a mobile phone, smart phone, tablet, computer,laptop, watch or other wireless device. The data may also be sent to adevice at a remote destination. The remote destination device may be alocally operated mobile or portable device, such as a smart phone,tablet device, pad, or laptop computer. The destination may also besmart phone, pad, computer, cloud device, or server. In otherembodiments, the remote destination may be a stand-alone or networkedcomputer, cloud device, or server accessible via a local portabledevice. A diagnosis of an infection in an aquatic environment may bebased on the analyte quantity. The diagnosis may be based on the use ofone or more immunoglobulins as detection materials.

The method may optionally include the step of disposing of the testsample composition 1216 per legal requirements. Such legal requirementsassure that any sample still containing unacceptable levels ofpathological contamination are disposed of properly so as not to causeharm to a user or the environment.

According to one embodiment, the method further includes the step ofinitiating 1218 a cleaning or remedial countermeasure against anyanalyte detected. Such remedial measure may include introducing cleaningchemicals or beneficial microorganisms to the aquatic environment. Theremedial measures may work to kill or otherwise neutralize any unwantedanalyte present in the aquatic environment where a sample was taken.

Although the present specification describes components and functionsthat may be implemented in particular embodiments with reference toparticular standards and protocols, the invention is not limited to suchstandards and protocols. For example, standards for Internet and otherpacket switched network transmission (e.g., TCP/IP, UDP/IP, HTML, HTTP)represent examples of the state of the art. Such standards areperiodically superseded by faster or more efficient equivalents havingessentially the same functions. Accordingly, replacement standards andprotocols having the same or similar functions as those disclosed hereinare considered equivalents thereof.

Although specific embodiments of the present disclosure are hereinillustrated and described in detail, the disclosure is not limitedthereto. The above detailed descriptions are provided as exemplary ofthe present disclosure and should not be construed as constituting anylimitation of the disclosure. Modifications will be apparent to thoseskilled in the art, and all modifications that do not depart from thespirit of the disclosure are intended to be included with the scope ofthe appended claims.

Prophetic Example 1 Cholera and Cyanobacteria Detection andQuantification

A point of use testing unit may be set up to aid in rapid detection andquantification of cyanobacteria, cholera (Vibrio cholera), or acombination thereof in a surface water source. Cholera and cyanobacteriaare known to maintain a symbiotic relationship so there may be a need totest for both analytes.

A user may obtain a sample from the water source. A cartridge is thenplaced inside the system's detector component, if not already present.The cartridge may be fully replaceable and disposable after each use.The user may optionally then enter a user identifier (ID) in the systemand the system optionally transmits that information to the remoteserver for authentication or stores the information locally. Any of anumber of identifier labelling techniques, such as radio frequencyidentifiers (RFIDs) on or within a sample may be used. Alternatively, aunique serial number, code or other identifier associated with a samplemay be manually entered into the system and optionally transmitted to aremote server. Additionally, the user may use the system to scan in ormanually enter one or more substance/contaminant identifiers, such as aUniversal Product Code (UPC) for the one or more analytes believed to bepresent in the sample and to inform the remote server of the one or moreanalytes. The system may also include geolocation information in itscommunications with the server, either from a GPS sensor included in thesystem or a GPS software function capable of generating the location ofthe system in cooperation with a cellular or other communication networkin communication with the system.

For detection and quantification of a cyanobacteria, one or moreantibodies specific to the cyanobacteria will be included on thereceptor layer. The antibodies may be specific to microcystins such asmicrocystin-LR that are found in connection with cyanobacteria.

If present, the user may initialize the system by pressing a startbutton or other similar means to initiate any electronic componentspresent in the system. If present, the user may optionally press aninjection bulb or similar mechanical component to inject a buffersolution into the cartridge. Any display on the system may then providevisual signal that the system is ready for sample introduction (e.g.,signal “READY”). If present, the user may then press another externaldisplay or button to signal the system that a sample is ready to beintroduced (e.g., “SAMPLE”).

To introduce a sample, an aliquot of the sample may be added through asample collecting component. Such a step may be accomplished via adisposable pipette or similar device that is suited for storing a sampleuntil needed. Next, a user may press the injection bulb or similarmechanical component to mix the aliquot of sample and buffer andintroduce the mixture to the cartridge. According to an alternativeembodiment, the buffer may be mixed with the aliquot sample in aseparate step prior to introduction to the cartridge. A user may thenpress the injection bulb or similar mechanical component a one or moretimes to ensure the sample mixture has fully transitioned or otherwisemigrated to the cartridge and begins flowing across the waveguidechannels on the waveguide. Upon arrival at the waveguide, detection andquantification processes are undertaken. Depending on the goal of thepoint of use procedure, one or more analytes in the sample will bind tothe receptor surface of the waveguide channels thereby altering theevanescent field above the waveguide channels. The changes in theinterference pattern will then create an electronic signal that can betranslated to produce a reading on a display on an external surface ofthe system. Any collection devices and used interferometric cartridgesused during use may then be disposed of properly in an appropriate wastecontainer. The cartridge within the system may then be removed andreplaced with a new cartridge or cleaned prior to next use. Thecartridge may be fully disposable and placed in an appropriate wastecontainer.

Prophetic Example 2 Ground Water Analyte Detection

A point of use testing unit may be set up to aid in rapid detection andquantification of one or more target analytes in a subterranean watersource (e.g., ground water). A user may obtain a sample from the watersource and carry out the steps as set forth with respect to Example 1.The targeted analytes may include any chemical contaminant including,but not limited to, a volatile organic compound such as benzene,toluene, ethylbenzene and xylenes), tetrachloroethylene (PCE),trichloroethylene (TCE), vinyl chloride (VC), and gasoline. Otherchemical contaminants include oil, nitrites, metals, and pesticides.

We claim:
 1. A method of detecting and quantifying the level of analytein an aquatic test sample, the method comprising the steps of:collecting an aquatic test sample containing one or more analytes;introducing the aquatic target sample to a portable interferometricsystem; initiating waveguide interferometry on the aquatic test sample;and processing any data resulting from the waveguide interferometry,wherein the interferometric system comprises: an optical assembly unit,the optical assembly unit comprising a light unit and a detector uniteach adapted to fit within a portable housing unit; and a cartridgesystem adapted to be inserted in the housing unit and removed after oneor more uses, the cartridge system comprising: an interferometric chipincluding one or more waveguide channels having a sensing layer thereon,the sensing layer adapted to selectively bind or otherwise beselectively disturbed by one or more analytes within the aquatic testsample; and a flow cell wafer; and a cartridge housing enclosing theinterferometric chip and flow cell wafer; and an alignment means foraligning the cartridge system within a cartridge recess in the opticalassembly unit upon insertion thereby providing optical and microfluidicalignment of the interferometric chip and flow cell wafer.
 2. The methodof claim 1, further comprising the step of wirelessly transmittinganalyte detection and quantification data to a mobile device or server.3. The method of claim 1, further comprising the step of displaying datarelated to the presence of analyte in the aquatic test sample on adisplay unit of the interferometric system.
 4. The method of claim 1,wherein the aquatic target sample is collected from a surface watersource.
 5. The method of claim 1, wherein the aquatic target sample iscollected from a ground water source.
 6. The method of claim 1, whereinthe aquatic target sample is collected from salt water, fresh water,fish farm, effluent system, waterway, water reservoir, potable watersource, or sanitary sewer.
 7. The method of claim 1, wherein the aquatictarget sample is in the form of, dissolved in, or suspended in a liquidor a gas.
 8. The method of claim 1, wherein the data resulting from thewaveguide interferometry is provided at or under 30 minutes afterinitiating waveguide interferometry on the aquatic test sample.
 9. Themethod of claim 1, wherein the cartridge housing comprises a vent portfor allowing air to exit and prevent bubble formation.
 10. The method ofclaim 1, wherein the one or more analytes includes one or moreantibodies, virus antigens, virus proteins, bacteria, fungi, pathogen,RNA, chemical, mRNA or any combination thereof.
 11. The method of claim1, wherein the one or more analytes includes cyanobacteria or cholera(Vibrio cholera).
 12. The method of claim 11, wherein the sensing layerincludes one or more antibodies adapted to bind one or morecyanobacteria.
 13. The method of claim 1, wherein the one or moreanalytes includes a volatile organic compound, oil, nitrite, metal, orpesticide.
 14. The method of claim 1, wherein the one or more analytesincludes benzene, toluene, tetrachloroethylene (PCE), trichloroethylene(TCE), vinyl chloride (VC), or gasoline.
 15. The method of claim 1,further comprising the step of initiating a cleaning or remedialcountermeasure against any one or more analytes detected.
 16. The methodof claim 1, the interferometric system having an analyte detection limitdown to about 1.0 picogram/L.
 17. The method of claim 1, theinterferometric system having an analyte detection limit down to about1000 pfu/ml.
 18. The method of claim 1, wherein the detector hassensitivity to at least 2 pixels per diffraction line pair.
 19. Themethod of claim 1, the interferometric system further comprising alocation means adapted to determine the physical location of theinterferometric system.
 20. The method of claim 1, wherein the sensinglayer includes one or more antigens, antibodies, DNA microarrays,polypeptides, nucleic acids, carbohydrates, lipids, or molecularlyimprinted polymers, or immunoglobulins suitable for binding one or moreanalytes within an aquatic test sample composition.